Real-World Progression-Free Survival and Healthcare Resource Utilization Associated with Daratumumab Use in Transplant-Ineligible Multiple Myeloma Patients in Italy
Purpose: This study evaluated real-world clinical and economic outcomes associated with daratumumab-based regimens in patients with multiple myeloma (MM) ineligible for autologous stem cell transplantation (ASCT) in Italy. Differences in healthcare resource use according to daratumumab administration route (intravenous vs subcutaneous) were also explored.
Methods: A retrospective observational analysis was conducted using administrative healthcare databases from Italian Local Health Units covering ~12 million individuals (2018– 2023). Patients with MM receiving daratumumab in first-line (1L) or second-line (2L) therapy were included. Real-world progression-free survival (rwPFS), defined as time to treatment switch or death, was used as a proxy endpoint for disease progression, and healthcare resource utilization were compared between treatment regimens. Propensity score weighting was applied to to improve comparability between treatment groups. Direct healthcare costs captured in administrative databases were analyzed from the perspective of the Italian National Health System.
Results: Among 790 non-ASCT MM patients, 344 received 1L DaraRd and 413 received 2L DaraRd. In the 1L setting, median rwPFS was not reached for DaraRd and was 25.7 months for Rd (p=0.011). In 2L, median rwPFS was 42.9 months for DaraRd versus 19.1 months for Rd (p < 0.001). In 1L, DaraRd was associated with lower hospitalization costs compared with Rd for both all-cause (€ 4324 vs € 7971) and MM-related (€ 2862 vs € 6693) admissions. In 2L, differences in hospitalization costs were smaller and not statistically significant.
Conclusion: In this real-world analysis, daratumumab-based regimens were associated with longer rwPFS compared with Rd among transplant-ineligible MM patients, in both 1L and 2 L settings. In 1L treatment, these outcomes were accompanied by lower hospitalization costs. Given the retrospective design and the use of administrative healthcare data, these findings should be interpreted with caution, but they contribute to the growing body of real-world evidence on treatment outcomes and resource utilization in routine clinical practice.
Epidemiologic Characteristics Determining the Choice ofDirect-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study
AbstractPangenotypic direct-acting antivirals (pDAAs) have transformed hepatitis C virus (HCV) treatment. In Italy, sofosbuvir/velpatasvir (SOF/VEL) and glecaprevir/pibrentasvir (GLE/PIB) are available. While both show similar efficacy, differences in patient profilesand potential drug–drug interactions (DDIs) may influence treatment choice. This study examined factors affecting pDAA selection and potential prescribing gaps. Using administrative databases (2018–2023) covering 3.7 million… Read More »Epidemiologic Characteristics Determining the Choice ofDirect-Acting Antiviral Therapy in HCV Patients: An Italian Real-World Evidence Study
Characteristics, therapeutic pathway and the economicburden of patients with drug-resistantepilepsy: A real-world analysis following the introduction of cenobamate inItaly
Abstract Objectives: Drug-resistant epilepsy (DRE) remains a major clinical challenge, affecting approximately one-thirdof patients with epilepsy. Cenobamate, a novel antiseizure medication (ASM) approved in Italy in 2022, has shown promisein clinical trials. However, real-world data on its use, especially economic evaluations, remain limited. This analysis assessed the impact of cenobamate in Italian clinical practice, focusing… Read More »Characteristics, therapeutic pathway and the economicburden of patients with drug-resistantepilepsy: A real-world analysis following the introduction of cenobamate inItaly
The economic impact of multimorbidity in Italy:evaluation of direct costs and scenario analysis ofpatients with type 2 diabetes, heart failure, andchronic kidney disease using real-world data
ABSTRACTObjectives: This study aimed to evaluate the healthcare costs associated with managing type 2 diabetes (T2D),chronic kidney disease (CKD), and heart failure (HF) in Italy. Specifically, the research investigated the economicimpact on the Italian National Health System due to the increased clinical complexity and multimorbidity amongpatients with these conditions.Methods: A predictive model was developed to… Read More »The economic impact of multimorbidity in Italy:evaluation of direct costs and scenario analysis ofpatients with type 2 diabetes, heart failure, andchronic kidney disease using real-world data
RWE in oncologia: uso dei database per identificare isottotipi molecolari del cancro mammario metastatico in Italia
Introduction: The use of Real-World Evidence (RWE) is gaining increasing relevance in oncology, offering a complementaryperspective to randomised clinical trials (RCTs). In Italy, administrative databases represent a promisingsource to explore treatment patterns and distribution of molecular subtypes in metastatic breast cancer(mBC). This study was aimed at evaluating the feasibility and accuracy of using administrative data… Read More »RWE in oncologia: uso dei database per identificare isottotipi molecolari del cancro mammario metastatico in Italia
Healthcare Costs and Treatment Patterns of Triplet Therapies in Relapsed/Refractory Multiple Myeloma: Real World Evidence from Italy
Purpose: This analysis sought to characterize patients with relapsed or refractory multiple myeloma (RRMM) on triplet therapy with immunomodulatory agents/proteasome inhibitors/monoclonal antibodies combined with dexamethasone, describing their demographic and clinical features, therapeutic pathways and the related healthcare costs for the Italian National Health Service (NHS).Patients and Methods: A retrospective observational analysis was conducted on administrative… Read More »Healthcare Costs and Treatment Patterns of Triplet Therapies in Relapsed/Refractory Multiple Myeloma: Real World Evidence from Italy
A Real-World Analysis of Patientswith Triple Class Exposed Multiple Myeloma in Italy: Epidemiology Estimates, Treatment Pattern and Economic Burden
ABSTRACTOBJECTIVES: This research aimed to provide updated epidemiological estimates of multiple myeloma (MM) in Italy andto characterize the clinical journey, treatment patterns, and economic burden focusing specifically on the subset of patientswho have been exposed to all three major therapeutic classes: proteasome inhibitors, immunomodulatory drugs, and anti-CD38 monoclonal antibodies (triple-class exposed, TCE).METHODS: A retrospective analysis… Read More »A Real-World Analysis of Patientswith Triple Class Exposed Multiple Myeloma in Italy: Epidemiology Estimates, Treatment Pattern and Economic Burden
Treatment Pathways, Drug Utilization and Healthcare Resource Consumption in Patients with Metastatic Anaplastic Lymphoma Kinase-Positive Non-small Cell Lung Cancer: A Real-World Analysis with Administrative Databases in Italy
Background: Metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) is a rare but clinically distinct subtype of lung cancer with therapeutic sensitivity to ALK inhibitors (ALKi). Over the past decade, several ALKi have been introduced in Italy, yet real-world data on their utilization, patient characteristics, outcomes, and healthcare burden remain limited. Objectives: This… Read More »Treatment Pathways, Drug Utilization and Healthcare Resource Consumption in Patients with Metastatic Anaplastic Lymphoma Kinase-Positive Non-small Cell Lung Cancer: A Real-World Analysis with Administrative Databases in Italy
The Integrated Multidisciplinary Pathway for Large-Scale Management of Dyslipidemia in High-Risk Patients (ENNA) Project: Rationale and Project Design
Atherosclerotic cardiovasculardiseaseisaleadingcauseofmorbidityandmortalityglobally,significantlyinfluenced bymodifiable riskfactors,particularlyhypercholesterolemia.Despitetheavailabilityofeffectivelipid-reducing drugs,achievingthelow-densitylipoproteincholesterol(LDL-C)targetlevelsremainsasignif-icant challengeinclinicalpractice,contributingtopersistentlyhighratesofcardiovascularevents.TheintE-grated multidiscipliNarypathwayforlarge-scalemaNagementofdyslipidemiAinhigh-riskpatients(ENNA)Project wasdesignedtoaddressthealarmingratesofsuboptimallipidmanagementinpatientsathighandvery-high riskintheprovinceofEnna,Sicily.ThisprogramaimstooptimizeLDL-Ccontrolthroughaninte-grated caremodelthatfosterscollaborationamongpharmacists,generalpractitioners,andcardiologists,ulti-mately promotingapatient-centeredapproachtotherapy.Thepatientswhoareeligibleareidentified usingdata-driven methodsthroughprescriptionclaims,laboratoryresults,andhospitaldischargedata,facilitatedby localpharmacies.Generalpractitionersplayacrucialroleastheprimarycareprovidersforinitiatingoroptimizing lipid-reducingtherapy,whereascardiologistsareinvolvedinmanagingmorecomplexcasesrequiring specializedintervention.TheprimaryobjectiveoftheENNAProjectistoincreasethepercentageofpatients atgreatriskinwhomLDL-Ctargetsareachieved,improvingoveralllipidmanagementandthera-peutic adherence.